FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
- Recall number
- Z-0328-2018
- Recalling firm
- Encore Medical, Lp
- Product
- EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
- Status
- Terminated
- Initiated
- 2017-12-12
- Posted
- not on file
- Terminated
- 2022-06-13
- Reason
- The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
- Root cause
- Device Design
- Action
- The field safety notice was disseminated by email on 12/12/2017. The notice stated the following: "DJO Sales Agents Action: Please review the bulletin that is provided with this notice. This bulletin contains new instructions on the use of the Locking Punch Guide and Punch. Please ensure your surgeons are familiar with this information. DJO Surgical then requires that you complete the attached acknowledgment and email it to teffany.hutto@djoglobal.com. Please have this form returned by December 15, 2017 Once redesigned guides are available, they will be exchanged through a separate field action."
- Quantity
- 2 units
- Distribution
- One medical device distributor in California.
- Lot, serial or model codes
- Lot 252564
- 510(k) numbers
- ["K100900"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28